Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Neonatal Staphylococcal Sepsis

In brief

"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S. epidermidis Infection." The purpose of this study is to evaluate the safety and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.

Key facts

Study ID

NCT00631878

Run by

Biosynexus Incorporated

People needed

53

Starts

2001-11-01

Expected to finish

2003-08-01

Last updated by the study team

2008-03-10

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the following criteria at the time of first infusion (Day 0):
• 3-7 days of age, inclusive
• Birth weight of 700-1300 grams
• Survival expected for at least 1 week after infusion
• Inpatient in a Neonatal Intensive Care Unit with intravenous access
• Written informed consent obtained from the parent(s) or guardian
• Multiple gestations:
• Siblings from multiple gestations may be enrolled if they each meet the entry criteria
• No more than 4 subjects in any birth weight or dose cohort may be siblings

You may not qualify if…

• Patients may have none of the following at either the first or second dose:
• Clinically overt systemic infection, as determined by history, physical examination, culture or laboratory data. Neonates with known or suspected HIV infection but without other active systemic infection are not excluded.
• Life threatening hemodynamic instability
• Severe congenital anomalies or genetic disorders (especially any predisposing to cardiac decompensation) as determined by history and/or physical examination and including but not limited to:
• i. Trisomy 13 ii. Trisomy 18 iii. Hypoplastic Left Heart Syndrome iv. Omphalocele v. Gastroschesis vi. Holoprosencephaly
• Known or suspected hepatic or renal insufficiency
• Persistent seizure disorder
• Immunodeficiency other than due to prematurity
• A history of immune globulin administration prior to first study drug infusion
• Any history, in the infant subject or its mother, of a hypersensitivity or severe vasomotor reaction to immunoglobulin G, or blood products.
• Any of the following laboratory findings
• BUN or creatinine > 1.5 x upper limit of normal for age
• AST (SGOT), ALT (SGPT) or total bilirubin > 1.5 x upper limit of normal age
• Direct bilirubin of > 2.0 mg/dL
• Hemoglobin < 9.0gm/dL
• White Blood Count < 2,000 cells/mm3
• Currently receiving or recently received other investigational agents that could interfere with conduct or results of this study. Each patient receiving other investigational agents will be reviewed by the investigator or his designee with the Sponsor prior to the patient's entry into the study.
• Expectation that the patient will not be able to be followed for the duration of the study.
• Mother with serology positive for hepatitis B surface antigen
• Receipt of Hepatitis B vaccine since birth

Where it is running

• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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